U.S. groups revise guidelines on anemia drugs
Last Updated: 2007-10-23 11:00:56 -0400 (Reuters Health)
WASHINGTON (Reuters) - Anemia drugs sold by Amgen Inc and Johnson & Johnson should not be given to cancer patients who are not undergoing chemotherapy, two medical groups said in updated guidelines released on Monday.
The American Society of Clinical Oncology (ASCO) and the American Society of Hematology (ASH) also said the anemia drugs should be discontinued if a patient does not respond within six to eight weeks.
The guidelines were developed by a panel of experts who reviewed scientific data on the medicines, which include Amgen's Aranesp and Johnson & Johnson's Procrit.
Sales of the widely used medicines have fallen this year after studies linked some uses to higher rates of heart attacks, strokes and death and regulators added a strong "black box" warning.
The new recommendations are "evidence-based, done by the experts in the field. They should be followed," said Dr. Joseph Bailes, chair of ASCO's government relations council, in an interview.
The guidelines are an update from a 2002 version and were published by the peer-reviewed journals Blood and the Journal of Clinical Oncology.
Five of 13 authors reported accepting funding from Amgen or Johnson & Johnson.
The drugs are erythropoiesis-stimulating agents, or EPO drugs. They also are used to treat anemia in kidney disease patients.
The cancer experts said they advised against giving the medicines to cancer patients not undergoing chemotherapy "since recent trials report increased (clotting) risks and decreased survival under these circumstances."
Non-chemotherapy use in cancer is not approved by the Food and Drug Administration.
The guidelines also recommend giving the drugs in cancer patients on chemotherapy when their blood hemoglobin approaches or falls below 10 grams per deciliter, and that hemoglobin can be raised to near 12 grams per deciliter.
Both ASCO and ASH have advocated that position to Medicare, the federal health insurance program for the elderly and disabled. ASCO, ASH and Amgen have said Medicare's policy is too restrictive.
Amgen said in a statement it "respects ASH and ASCO's extensive review of the best available and most recent medical evidence."
Ortho Biotech, the Johnson & Johnson unit that makes Procrit, said the new guidelines "should help physicians make the best treatment decisions for their patients."
